During the BIO 2015 Convention in Philadelphia, there were several sessions directed to biosimilars. Biologic medicines now account for about one-third of annual drug approvals in the US (according to the Pharmaceutical...more

With the recent announcement of Sarepta’s filing for approval of its drug, eteplirsen, for the treatment of Duchenne muscular dystrophy (DMD), coming on the heels of BioMarin’s announcement a few months earlier of a similar...more

The U.S. Food and Drug Administration (FDA) does not frequently issue Warning Letters to corporate sponsors of FDA-regulated clinical trials, so the June 16, 2015, Warning Letter sent to AB Science, a pharmaceutical company...more

Happy birthday, Louise Fletcher, who won an Academy Award for her portrayal of the sadistic Nurse Ratched in One Flew Over the Cuckoo’s Nest (1975). Happy birthday also to Albert Brooks, writer/director/star of Modern...more

In Amgen v. Sandoz, a divided panel of the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that appears to favor biosimilar applicants...more

Although Inter Partes Review (IPR) is limited to grounds of unpatentability based upon prior art references, it is nevertheless possible to raise issues of written description or enablement by applying intervening prior art...more

Last month, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services released a comprehensive report and data brief detailing its concerns about the ability of Medicare Part D sponsors – as...more

This year China’s Advertising Law will see its first amendment in two decades. The amendment, which will be implemented on September 1, 2015, reflects the central government’s efforts to strengthen consumer protection and to...more

Drug Approval and Patent Listing Process -
Before being allowed to market a new drug1 in the U.S., branded drug manufacturers must submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), and...more

In This Issue:
- Judgments; Legislation; and Reports.
- Excerpt from Judgements:
United Kingdom (UK)
7 July 2015 - Ross v A [2015] EWCOP 46
The England and Wales Court of Protection has held that a...more

On Friday, July 10th the U.S. House voted overwhelmingly to streamline the approval process of prescription drugs and medical devices by the FDA. If passed in the Senate and signed by President Obama, the “21st Century Cures...more

The Therapeutic Goods Act 1989 (Cth)(TG Act):
- Provides a national framework for the regulation of medicinal products.
- Provides a national system to control the quality, safety, efficacy and timely availability...more

Conditions and legislation
Australian patent law is governed by the Patents act 1990 (Cth) (Patents Act). The Patents Act provides for the grant of two main types of patents in Australia:
- Standard, which is...more

Drug compounding as a practice has, until recently, been met with far looser regulation than the manufacture of drugs. This practice serves to meet the needs of individuals who require certain formulations not available in...more

On June 29, 2015, the Centers for Medicare & Medicaid Services (“CMS”) published detailed information regarding payments made by pharmaceutical and medical device manufacturers to physicians and teaching hospitals during 2014...more

The learned intermediary doctrine – in which a manufacturer’s duty to warn runs to the physician, not to the patient – is one of the most potent weapons in the arsenal for a pharmaceutical or medical device manufacturer faced...more

On June 19, the whistleblower in a False Claims Act suit argued that the court should take action to secure documents that demonstrate Abbott Laboratories encouraged off-label marketing and doctor kickbacks. The whistleblower...more

What are the latest trends on product recalls in the United States?
Consumer Products. The Consumer Product Safety Commission has been proactive in recent years with consumer product regulations and recalls,...more

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